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Daunorubicin-Cytarabine Liposome (Vyxeos) (CPB 0921, reviewed 2026-06-12)

Aetna·Oncology, Hematology, Internal Medicine·Medical Policy
Effective date
Jun 12, 2026
We identified it
Aug 13, 2026
Days to comply

Summary

Aetna has updated its clinical policy for Vyxeos (daunorubicin-cytarabine liposome) effective immediately, establishing specific medical necessity criteria for initial approval, continuation of therapy, and dosage/administration guidelines for AML, MDS, and CMML treatment. Billing teams must now enforce prior authorization requirements based on diagnosis type, therapy phase (induction/consolidation/re-induction), and cycle limits to ensure claim approval.

Action Required

Action needed
Effective immediately (policy reviewed 2026-06-12): Billing team must implement prior authorization requirements for all Vyxeos claims before submission. (1) Update billing software to require prior auth for HCPCS code J9153 when billed with specific ICD-10 codes (C92.00-C92.62, C93.10-C93.12, D46.0-D46.Z). (2) Verify diagnosis codes match approved indications: t-AML (other than CBF-AML), AML from MDS/CMML, AML-MRC, or poor-risk AML with TP53/del(17p). (3) Enforce cycle limits in prior auth: maximum 2 induction cycles (including re-induction) and maximum 2 consolidation cycles. (4) Require documentation of no unacceptable toxicity after first cycle for continuation approvals. (5) Update encounter forms and EMR templates to capture therapy phase (induction/consolidation/re-induction) and cycle number at point of service. (6) Reject or reroute claims for non-approved indications (e.g., CBF-AML, APL, other diagnoses) as experimental/investigational. (7) Train billing staff that Vyxeos dosing differs by therapy phase (44/100 mg/m² induction vs. 29/65 mg/m² consolidation) and requires accurate documentation. Consequences: Claims submitted without prior authorization or exceeding cycle limits will be denied; claims for non-covered diagnoses will be denied as investigational.

Affected Billing Codes

96413
96414
96415
96416
96417
J9153
J9100
C92.00
C92.10
C92.20
C92.30
C92.40
C92.50
C92.60
C92.61
C92.62
C92.A0
C92.A1
C92.A2
C93.10
C93.11
C93.12
D46.0
D46.1
D46.2
D46.20
D46.21
D46.22
D46.9